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Neupro (Rotigotine) HIGHLIGHTS OF PRESCRIBING INFORMATION Transdermal System: 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg rotigotine per These highlights do not include all the information needed to use 24 hours. (3) NEUPRO safely and effectively. See full prescribing information for ------------------------------CONTRAINDICATIONS------------------------------ NEUPRO. History of hypersensitivity to rotigotine or components of the transdermal patch. (4) Neupro (Rotigotine Transdermal System) Initial U.S. Approval: 2007 -----------------------WARNINGS AND PRECAUTIONS----------------------- Contains sodium metabisulfite that may cause allergic-type reactions in ---------------------------RECENT MAJOR CHANGES--------------------------- those with sulfite sensitivity. (5.1) Indications and Usage, Parkinson’s Disease (1.1) 04/2012 Falling asleep during activities of daily living, including the operation Indications and Usage, Restless Legs Syndrome (1.2) of motor vehicles and somnolence may occur. (5.2) 04/2012 Hallucinations/psychotic -like behavior and dyskinesia may occur. (5.3, Dosage and Administration, Advanced-Stage Parkinson’s Disease (2.1) 5.9) 04/2012 Symptomatic postural hypotension and syncope may occur, especially Dosage and Administration, Restless Legs Syndrome (2.2) during dose escalation. (5.4, 5.5) 04/2012 Application site reactions can occur, and may be severe. (5.10) Warnings and Precautions (5) 4/2012 Elevation of blood pressure and heart rate may occur. (5.7) Intense urges may cause impulse control and compulsive behaviors. ---------------------------INDICATIONS AND USAGE--------------------------- (5.6) Neupro is a dopamine agonist indicated for the treatment of: Monitor patients for these adverse reactions. If these adverse reactions Signs and symptoms of Parkinson’s disease (1.1) occur, lowering the dose or discontinuing Neupro may be beneficial. (5) Moderate-to-severe primary Restless Legs Syndrome (1.2) ------------------------------ADVERSE REACTIONS------------------------------ -----------------------DOSAGE AND ADMINISTRATION----------------------- Most common adverse reactions (> 5 % greater than placebo) for the Apply once a day to the skin; press firmly in place for 30 seconds, making highest recommended doses of Neupro for treatment of Parkinson's good contact. Do not place Neupro on oily, irritated, or damaged skin, or disease were nausea, vomiting, somnolence, application site reactions, where it will be rubbed by tight clothing. Do not use the same site more than dizziness, anorexia, hyperhidrosis, insomnia, peripheral edema, and once every 14 days. The prescribed dose may be achieved using single or dyskinesia. (6.1) multiple patches. (2) Most common adverse reactions (> 5 % greater than placebo) for the Parkinson’s disease: Initially, 2 mg/24 hours for early-stage disease or 4 highest recommended dose of Neupro for Restless Legs Syndrome were mg/24 hours for advanced-stage disease. The dose may be increased as application site reactions, nausea, somnolence, and headache.(6.1) needed by 2 mg/24 hours at weekly intervals, up to 6 mg /24 hours for To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at early-stage disease and up to 8 mg/24 hours for advanced-stage disease. 866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (2.1) Restless Legs Syndrome: Initially, 1 mg/24 hours, increased as needed by ----------------------USE IN SPECIFIC POPULATIONS-------------- 1 mg/24 hours at weekly intervals, up to 3 mg/24 hours. (2.2) Pregnancy: Based on animal data, may cause fetal harm (8.1) To discontinue treatment, reduce the dose gradually until complete withdrawal See 17 for PATIENT COUNSELING INFORMATION and FDA of Neupro. (2.3) approved patient labeling. Revised: 04/2012 ---------------------DOSAGE FORMS AND STRENGTHS--------------------- _______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* 8.3 Nursing Mothers 1 INDICATIONS AND USAGE 8.4 Pediatric Use 1.1 Parkinson’s Disease (PD) 8.5 Geriatric Use 1.2 Restless Legs Syndrome (RLS) 8.6 Renal Impairment 2 DOSAGE AND ADMINISTRATION 8.7 Hepatic Impairment 2.1 Parkinson’s Disease 9 DRUG ABUSE AND DEPENDENCE 2.2 Restless Legs Syndrome 9.1 Controlled Substance 2.3 Discontinuation of Treatment 9.3 Dependence 3 DOSAGE FORMS AND STRENGTHS 10 OVERDOSAGE 4 CONTRAINDICATIONS 10.1 Overdose Symptoms 5 WARNINGS AND PRECAUTIONS 10.2 Overdose Management 5.1 Sulfite Sensitivity 11 DESCRIPTION 5.2 Falling Asleep During Activities of Daily Living and 11.1 System Components and Structure Somnolence 12 CLINICAL PHARMACOLOGY 5.3 Hallucinations / Psychotic-Like Behavior 12.1 Mechanism of Action 5.4 Symptomatic Hypotension 12.2 Pharmacodynamics 5.5 Syncope 12.3 Pharmacokinetics 5.6 Impulse Control / Compulsive Behaviors 12.6 Pharmacokinetics in Special Populations 5.7 Elevation of Blood Pressure and Heart Rate 12.7 Adhesion 5.8 Weight Gain and Fluid Retention 13 NONCLINICAL TOXICOLOGY 5.9 Dyskinesia 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.10 Application Site Reactions 13.2 Animal Toxicology and/or Pharmacology 5.11 Melanoma 14 CLINICAL STUDIES 5.12 Augmentation and Rebound in RLS 14.1 Parkinson’s Disease 5.13 Magnetic Resonance Imaging and Cardioversion 14.2 Restless Legs Syndrome 5.14 Heat Application 16 HOW SUPPLIED/STORAGE AND HANDLING 5.15 Withdrawal-Emergent-Hyperpyrexia and Confusion 17 PATIENT COUNSELING INFORMATION 5.16 Fibrotic Complications 17.1 Sulfite Sensitivity 5.17 Binding to Melanin 17.2 Falling Asleep During Activities of Daily Living and 6 ADVERSE REACTIONS Somnolence 6.1 Clinical Trials Experience 17.3 Hallucinations / Psychotic-Like Behavior 6.2 Laboratory Changes 17.4 Symptomatic Hypotension 7 DRUG INTERACTIONS 17.5 Syncope 7.1 Dopamine Antagonists 17.6 Impulse Control / Compulsive Behaviors 8 USE IN SPECIFIC POPULATIONS 17.7 Elevation of Blood Pressure and Heart Rate 8.1 Pregnancy 17.8 Weight Gain and Fluid Retention Reference ID: 3108299 17.9 Dyskinesias 17.13Magnetic Resonance Imaging and Cardioversion 17.10Application Site Reactions 17.14 Heat Application 17.11 Melanoma 17.15Nausea, Vomiting, and Dyspepsia 17.12Augmentation and Rebound in RLS 17.16Instructions for Use *Sections or subsections omitted from the Full Prescribing Information are not listed. Page 2 Reference ID: 3108299 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Parkinson’s Disease (PD) Neupro (Rotigotine Transdermal System) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of Neupro was demonstrated in randomized, controlled trials in patients with early-stage Parkinson’s disease who were not receiving concomitant levodopa therapy as well as in patients with advanced-stage Parkinson’s disease on concomitant levodopa. 1.2 Restless Legs Syndrome (RLS) Neupro (Rotigotine Transdermal System) is indicated for the treatment of moderate-to-severe primary restless legs syndrome. 2 DOSAGE AND ADMINISTRATION Neupro is applied once a day. The adhesive side of the transdermal system should be applied to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm. The transdermal system should be applied at approximately the same time every day, at a convenient time for the patient. Because Neupro is administered transdermally, food is not expected to affect absorption and it can be applied irrespective of the timing of meals. No dosage adjustment is necessary for patients who have moderate impairment of hepatic function or mild to severe impairment of renal function. The application site for Neupro should be moved on a daily basis (for example, from the right side to the left side and from the upper body to the lower body). Neupro should not be applied to the same application site more than once every 14 days and should not be placed on skin that is oily, irritated, or damaged, or where it will be rubbed by tight clothing. If it is necessary to apply Neupro to a hairy area, the area should be shaved at least 3 days prior to Neupro application. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place for 30 seconds, making sure there is good contact, especially around the edges. If the patient forgets to replace Neupro, or if the transdermal system becomes dislodged, another transdermal system should be applied for the remainder of the day. The prescribed dose may be achieved using single or multiple patches. [Refer Patients to Instructions for Use in the Patient Information Section at the end of the Full Prescribing Information]. 2.1 Parkinson’s Disease Early-Stage Parkinson’s Disease Neupro should be started at 2 mg/24 hours for patients with early-stage Parkinson’s disease. Based upon individual patient clinical response and tolerability, Neupro dosage may be increased weekly by 2 mg/24 hours if tolerated and if additional therapeutic effect is needed. The lowest effective dose was 4 mg/24 hours. The highest recommended dose for early-stage Parkinson’s disease is 6 mg/24 hours. Advanced-Stage Parkinson’s Disease Patients with advanced-stage Parkinson’s disease may be initiated at 4 mg/24 hours. Based upon individual patient clinical response and tolerability, Neupro dosage may be increased weekly by 2 mg/24 hours. The recommended dose for advanced- stage Parkinson’s disease is 8 mg/24 hours. 2.2 Restless Legs Syndrome Neupro should be started at
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